MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA AMIS CUP IMPACTOR TERMINAL-M10; SURGICAL INSTRUMENT FOR HIP SURGERY

Catalog Number	01.15.10.0263
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/07/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Batch review performed on 09-august-2019 lot 1755175: (b)(4).No anomalies found related to the problem to date, no other similar events have been reported.Visual inspection performed by r&d project manager.During the analysis it is evaluated that the balinit-c coating of the terminal is removed from the area in connection with the cup, in addition some scratches are present of the whole body and finally the threaded part is damaged.Due to the damages indicated above the terminal was blocked in the cup as root cause.Additional device involved in the event, batch review performed on 09-august-2019 lot 1810201: (b)(4), expiration date: 2024-03-12.No anomalies found related to the problem to date, (b)(4) of the same lot have been already sold without any other similar reported event.
Event or Problem Description
After the surgeon impacted the cup, it was not possible to disconnect the terminal cup impactor.He had to explant the cup and use a new one with the straight cup impactor.There was a 5 minutes delay.

• Brand Name: AMIS CUP IMPACTOR TERMINAL-M10
• Common Device Name: SURGICAL INSTRUMENT FOR HIP SURGERY
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 8969653
• Report Number: 3005180920-2019-00738
• Device Sequence Number: 16913807
• Product Code: LXH
• UDI-Device Identifier: 07630040736015
• UDI-Public: 07630040736015
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 01.15.10.0263
• Device Lot Number: 1755175
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/05/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/07/2019
• Initial Report FDA Received Date: 09/06/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other